The U.S. Food and Drug Administration (FDA) on Thursday approved a Roche drug for the treatment of a chronic blood disorder, the Swiss drugmaker announced. Branded Piasky, clovalimab is administered as a monthly injection under the skin or intravenously to treat paroxysmal nocturnal hemoglobinuria (PNH).
PNH is a disease that causes the premature destruction of red blood cells, which can lead to anemia, fatigue, blood clots and kidney disease.
Roche said the disease affects about 20,000 people worldwide.
The approval was based on a late-stage study that showed that from weeks five to 25, Piasky controlled red blood cell destruction by 79.3%, versus 79% with the standard of care, eculizumab.
“Clovalimab offers the option to self-administer as frequently as once every four weeks, reducing the number of hospital visits for people suffering from this lifelong disease,” said Levi Garraway, Roche’s chief medical officer. Other treatments for PNH, including AstraZeneca’s eculizumab, sold as Ultomiris and Soliris, and Amgen’s Bkemv, require infusions by a health care professional.
Piasky was approved in China in February and in Japan in March.
The drug is also being tested in two other blood disorders, atypical hemolytic uremic syndrome and sickle cell disease, and a kidney disease called lupus nephritis.
